The creation of an ostomy (stoma) is the therapy for many sufferers of diseases or injury of the gastrointestinal or urinary tract. An ostomy is the rerouting of the tract through the abdominal wall to outside the patient's body. Once a stoma has been created, the patient must, usually for the rest of his or her life, use a device worn on the body for capturing or containing the body waste. This has traditionally been done with a bag or pouch attached to the body with adhesive patches or constricting belts. However, the wearing of such a pouch can be an extremely embarrassing and belittling experience for many ostomates. A pouch requires significant changes in public and personal activities.
A stoma plug offers the potential for an ostomate to return to some form of normality. The plug is used to block the stoma, in order to store body waste temporarily inside the tract. The plug is removable manually when the ostomate desires to discharge the body waste.
U.S. Pat. No. 4,950,223 describes an inflatable ostomy plug including a movable bellows located above a plate, and an inflatable bell-shaped bung below the plate. The inflatable bung is separate from the bellows and is mounted on a sliding inflation tube that moves with the bellows. The inflation tube extends through a sliding seal in the plate. In use, the ostomate can inflate the bung by compressing the bellows, which also causes the inflation tube to descend, thereby inflating the bung away from the bellows. The bung is deflated by an opposite movement of the bellows, which also causes the sliding tube to ascend with respect to the sliding seal.
Although the idea of an inflatable plug is highly appealing in theory, the plug described in U.S. Pat. No. 4,950,223 has significant potential disadvantages. Firstly, when the plug is inflated, the inflation tube is positioned substantially inside the stoma. The presence of such a relatively stiff tube inside the stoma may be undesirable in terms of safety for the ostomate. Secondly, it is not possible to vent flatus while the bung is inflated in the stoma. Flatus can only be vented when the bung is collapsed to allow discharge of body waste from the stoma. This presents severe limitations for the ostomate, because the ostomate will have to collapse the bung very frequently in order to avoid an uncomfortable accumulation of flatus within the body. Finally, the design of the plug is very complicated and therefore expensive, and the sliding seal may be prone to leakage of fluid. A leakage of fluid reduces the sealing pressure in the bung, and hence reduces the effectiveness of the plug.